Sentence examples for product comparability from inspiring English sources
It can be particularly useful when exploring alternative approaches for assessing product comparability especially in the context of encountering various complex experimental situations that can occur in veterinary medicine.
Regulatory concerns related to these issues as well as those related to newly identified product-related impurities, and demonstration of product comparability after manufacturing changes are made, are also discussed.
They also request that if a change is introduced to the manufacturing process of the biosimilar product, comparability studies should be carried out, and the comparability of the biosimilar products manufactured before and after such a change should be evaluated.
As with productivity, PQA, in particular, mAb glycosylation profiles have become more important due to the increasing need to demonstrate product quality comparability with both commercial products comparability and biosimilar initiatives.
The guidelines recommend that, following mandatory physician and patient discussion, substitution of an innovator drug for a biosimilar that used the innovator drug as a reference product for comparability (or vice versa) is acceptable.
Changing from a biosimilar from one manufacturer to a biosimilar from another manufacturer is also allowed if they used the same reference product for comparability, but patients should be closely monitored.
Despite this success, the future presents new challenges that include productivity increase, product quality modulation for comparability and biosimilarity, and efficient manufacturing of novel modalities.
In addition, lack of terminology for the products developed as copy products (so called "me too" products) with a partial comparability to an RBP, led to a great diversity in evaluating as well as naming these products.
Guidance issued by the European Medicines Agency (EMEA) states that new biosimilar medicinal products containing filgrastim should demonstrate comparability with the reference product, Amgen filgrastim [ 15].
Such a working database on the product would enable future comparability exercise in support of process upgrade or scale up to support expanding markets or alternative production facility.
If comparability of the biosimilar product and reference product is verified through quality evaluation, other toxicological studies are not generally required, unless triggered by results of the repeat-dose toxicity study and/or by other known toxicological properties of the reference product.
